Drug Catalog - Product Detail
Montelukast Sodium Oral Granules Packet 4 MG Base Equiv 30 EA UoU
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 59651-0329-30 | AUROBINDO PHARMA | 30 | 4MG | PACKAGE |
PACKAGE FILES
Generic Name
MONTELUKAST SODIUM
Substance Name
MONTELUKAST SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA213471
Description
11 DESCRIPTION Montelukast sodium, the active ingredient in montelukast sodium oral granules USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R -( E )]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The molecular formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18. The structural formula is: Montelukast sodium is a hygroscopic, optically active, white or almost white powder. Montelukast sodium is soluble in water, methanol, ethanol and practically insoluble in acetonitrile. Each packet of montelukast sodium 4 mg oral granules USP contains 4.2 mg montelukast sodium USP, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and mannitol. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Oral Granules USP, 4 mg are white to off white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: Unit of use carton with 30 packets NDC 59651-329-30 Storage Store montelukast sodium 4 mg oral granules USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
Indications & Usage
1 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in pediatric patients 12 months of age and older. 1.3 Allergic Rhinitis Montelukast sodium oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of montelukast sodium oral granules may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1) ] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. 1.4 Limitations of Use Montelukast sodium oral granules are not indicated for the treatment of an acute asthma attack.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 12 months and older ( 2.1 ). Seasonal allergic rhinitis: Once daily for patients 2 years and older (2.3) . Perennial allergic rhinitis: Once daily for patients 6 months and older (2.3) . Dosage (by age): 2 to 5 years: one packet of 4 mg oral granules (2) . 6 to 23 months: one packet of 4 mg oral granules (2) . Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4) . For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) (2.5) . 2.1 Asthma For asthma, administer montelukast sodium oral granules orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma * Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. Age Dose Pediatric patients 2 to 5 years of age one packet of 4 mg oral granules Pediatric patients 12 to 23 months of age* one packet 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 2.3 Allergic Rhinitis For allergic rhinitis, administer montelukast sodium oral granules orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: Table 3: Recommended Dosage in Seasonal Allergic Rhinitis * Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. Age Dose Pediatric patients 2 to 5 years of age* one packet of 4 mg oral granules The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: Table 4: Recommended Dosage in Perennial Allergic Rhinitis * Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. Age Dose Pediatric patients 2 to 5 years of age one packet of 4 mg oral granules Pediatric patients 6 to 23 months of age * one packet of 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 2.4 Asthma and Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one montelukast sodium dose orally once daily in the evening. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 2.5 Instructions for Administration of Oral Granules Montelukast sodium 4 mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, montelukast sodium oral granules must not be stored for future use. Discard any unused portion. Montelukast sodium oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. Montelukast sodium oral granules can be administered without regard to the time of meals.